ZOLEDRONIC ACID

Generic: ZOLEDRONIC ACID

BPI Labs LLCManufacturer
INTRAVENOUSRoute
ZOLEDRONIC ACIDActive Substance
2013-08-05Original Approval

ZOLEDRONIC ACID is FDA application ANDA202930, sponsored by GLAND. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2018-09-12
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma

Failed Impurities/Degradation Specifications: OOS for unknown impurities.

Class II2014-03-04
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Ster

Lack of Assurance of Sterility; leaking of premix bags

Top Reported Reactions

1
OSTEONECROSIS OF JAW
2,476 reports
2
FATIGUE
1,872 reports
3
NAUSEA
1,735 reports
4
DIARRHOEA
1,730 reports
5
PYREXIA
1,617 reports
6
OFF LABEL USE
1,581 reports
7
PAIN
1,425 reports
8
ARTHRALGIA
1,396 reports
9
VOMITING
1,391 reports
10
NEUTROPENIA
1,372 reports